Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Spasticity in Adult Patients With Spastic Cerebral Palsy

Reem Alharthi

Status: Completed

Conditions: Cerebral Palsy

Treatments: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Conventional physiotherapy treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05352607

HAPO-02-K-012-2022-01-912

Details and patient eligibility

About

Background: Cerebral palsy (CP) is a neurodevelopmental disorder caused by damage of the developing brain and marked by impairments such as increased muscle tone. Physical therapy (PT) is an important element for spasticity management include some modalities as transcutaneous electrical nerve stimulation (TENS).

Purpose: To determine the effect of TENS on inhibition of upper limb spasticity in adult patients with spastic cerebral palsy.

Methods: Twenty-four adult spastic CP patients aged from 18 to 45 years old with grade 2 to 3 spasticity according to Modified Ashworth Scale will be randomly assigned into two equal groups: TENS group and conventional therapy group. Both groups will receive conventional therapy, while TENS group in addition will receive TENS over elbow flexors with parameter setup of (pulse frequency= 100 Hz, pulse duration= 250 μs, time=30 mints) 3 sessions per week for successive 4 weeks.

Outcome measures: Modified Ashworth scale for the spasticity and digital goniometer for elbow joint range of motion, Barthel index scale for upper limb activity of daily living. Follow-up measures will be calculated three times (preintervention, post 2 weeks, and post 4 weeks).

Enrollment: 23 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients aged from 18 to 45 years old
• Diagnosed with spastic CP (upper limb is affected)
• Elbow flexor muscles spasticity grade 2 to 3 according to Modified Ashworth Scale
• Good cognition (patient able to follow the instruction)

Exclusion criteria

• Patient with epilepsy
• Under antispastic medication
• Severe psychological or behavioral problem
• Sensory abnormalities
• Orthopedic surgery or severe deformities in upper limb
• Injected by botulinum toxin (botox) in the past 6 months in upper limb.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

TENS group

Experimental group

Description:

TENS group will receive the conventional physiotherapy treatment plus TENS. TENS is most commonly used directly on affected muscles in patients with CP. The device will be used from Cosmogamma company (MIXING 2 (EVO): COMBINED THERAPY). It consists of 3 parts: the stimulator part, electrode and connected wires. Strap or plaster for electrodes adhesive with gel. Electrode diameter (6×4.5 cm). The program will be (Pain therapy - TENS - Free program - Modify -Parameter's setup). Parameter setup (pulse frequency= 100 Hz, pulse duration= 250 μs, time=30 minutes and the intensity according to patient to feel tingling sensation only and no muscle contraction).

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Control group

Active Comparator group

Description:

The Control group will receive the conventional physiotherapy treatment for upper limb spasticity only.

Treatment:

Other: Conventional physiotherapy treatment